BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2201185 · Received July 29, 2011

    Report

    Report Number
    1723170-2011-01251
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. (B)(4) ISSUED. SPRING ARM CABLE RETURNED TO MFR. INVESTIGATION OF CAMERA SPRING ARM ASSEMBLY FINDS THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED, HOWEVER, THE CABLE IS DAMAGED AT THE LEMO CONNECTOR EXPOSING THE SHIELD WIRE. REPLACEMENT PART SHIPPED (B)(6) 2011. SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A BIOMED REPRESENTATIVE REPORTED INTERMITTENT BLACK STATUS ON THE STEALTHSTATION TREON GUIDANCE SYSTEM CAMERA WHEN BOOTING UP THE SYSTEM. ATTEMPTED RE-BOOTING THE SYSTEM A NUMBER OF TIMES AND IT WORKED INTERMITTENTLY BY MANIPULATING THE LEMO CONNECTION FROM THE SPRING ARM CABLE INTO THE CAMERA, HOWEVER, THE SYSTEM IS NOT USABLE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1